Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

Summary

PRACTECAL-PRO is a sub-study of a TB-PRACTECAL clinical trial for multidrug resistant Tuberculosis. It evaluates the effectiveness of TB-PRACTECAL interventions from the patient perspective in terms of their quality of life, shared decision making and satisfaction with services.

Conditions

• Multidrug Resistant Tuberculosis

Interventions

DRUG

Bedaquiline

Bedaquiline is a diarylquinoline class antimicrobial which blocks the proton pump for ATP synthase of mycobacteria. This in turn blocks the ATP production required for cellular energy production and leading to cell death.

DRUG

Pretomanid

Pretomanid is a nitroimidazole class antimicrobial which interferes with cell wall biosynthesis in mycobacteria. It may have other mechanisms of action as well in non-replicating mycobacteria.

DRUG

Moxifloxacin

Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria

DRUG

Linezolid

Linezolid, an oxazolidinone class antimicrobial which works by inhibiting ribosomal protein synthesis. It is approved for Gram-positive bacterial infections, and is increasingly being used for drug resistant TB disease.

DRUG

Clofazimine

Clofazimine is a lipophilic riminophenazine licensed for treatment of leprosy. Its mechanism(s) of action remains unclear, but existing evidence suggests production of reactive oxygen species within Mycobacterium tuberculosis is one mechanism.

DRUG

Directly observed therapy (DOT)

Standard therapy

Sponsors & Collaborators

• University of Sussex

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• THINK TB & HIV Investigative Network

  collaborator NETWORK

• Wits Health Consortium (Pty) Ltd

  collaborator OTHER

• Ministry of Public Health, Republic of Belarus

  collaborator OTHER_GOV

• Ministry of Health, Republic of Uzbekistan

  collaborator OTHER_GOV

• Medecins Sans Frontieres, Netherlands

  lead OTHER

Principal Investigators

• Beverley Stringer · MSF

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-01

Primary Completion

2022-05-10

Completion

2022-05-10

Countries

• Belarus
• South Africa
• Uzbekistan

Study Locations